Flibanserin for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women in North America

Phase 3

Terminated

• Conditions: Sexual Dysfunctions, Psychological
• Interventions: Drug: Placebo; Drug: Flibanserin

• Registration Number: NCT01057901
• Lead Sponsor: Sprout Pharmaceuticals, Inc

Brief Summary

The objective of this trial is to assess the safety and efficacy of 24-week course of flibanserin for the treatment of Hypoactive Sexual Desire Disorder (HSDD) in naturally postmenopausal women.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-25
• Study First Submitted QC: 2010-01-27
• Study First Posted: 2010-01-28
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Results First Submitted: 2014-04-14
• Status Verified: 2014-06
• Results First Submitted QC: 2014-06-16
• Last Update Submitted: 2014-06-16
• Results First Posted: 2014-06-17
• Last Update Posted: 2014-06-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 748

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	This is the matched placebo which will be administered two tablets daily at bedtime.
Flibanserin 100 mg	Flibanserin	Flibanserin 100 mg administered at bedtime

Primary Outcome Measures

Name	Time	Method
Change From Baseline in the Number of Satisfying Sexual Events	baseline to 24 weeks	The change from baseline in the number of SSE's as measured by the eDiary. The calculation of Satisfying Sexual Event (SSEs) will be standardized to a 28-day period according to the below formula: Total monthly events = 28 x (sum of the number of events) / (sum of number of days entered).; "Satisfying" means gratifying, fulfilling, satisfactory, and/or successful for the patient. The partner's satisfaction is not the subject of this question.
Change From Baseline in the Score on the Female Sexual Function Index (FSFI) Desire Domain	baseline to 24 weeks	The Female Sexual Function Index (FSFI) is a brief, multidimensional, self-administered questionnaire for assessing key domains of sexual function in women. The scale consists of 19 items that assess sexual function over the past four weeks and yields scores in six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. The two items in the desire domain are scored from 1 to 5 (1 is lowest level of desire and 5 is the highest level of desire). The raw scores of the two items are added together and then multiplied by the domain factor of 0.6. Thus, the score of the desire domain ranges from 1.2 (lowest level of desire) to 6.0 (highest level of desire). For the entire instrument, each of the six domains contributes a maximum of 6 points to the total. Scores on the full scale range from a minimum of 2 to a maximum of 36.

Trial Locations

Locations (100)

511.156.01046 Boehringer Ingelheim Investigational Site; 🇺🇸 Plantation, Florida, United States

511.156.01040 Boehringer Ingelheim Investigational Site; 🇺🇸 Statesville, North Carolina, United States

511.156.01072 Boehringer Ingelheim Investigational Site; 🇺🇸 Medford, Oregon, United States

511.156.01079 Boehringer Ingelheim Investigational Site; 🇺🇸 Boston, Massachusetts, United States

511.156.01088 Boehringer Ingelheim Investigational Site; 🇺🇸 Las Vegas, Nevada, United States

511.156.01007 Boehringer Ingelheim Investigational Site; 🇺🇸 San Diego, California, United States

511.156.01049 Boehringer Ingelheim Investigational Site; 🇺🇸 San Antonio, Texas, United States

511.156.01010 Boehringer Ingelheim Investigational Site; 🇺🇸 Wichita, Kansas, United States

511.156.01039 Boehringer Ingelheim Investigational Site; 🇺🇸 Anaheim, California, United States

511.156.01063 Boehringer Ingelheim Investigational Site; 🇺🇸 Little Rock, Arkansas, United States

511.156.01064 Boehringer Ingelheim Investigational Site; 🇺🇸 Newport Beach, California, United States

511.156.01067 Boehringer Ingelheim Investigational Site; 🇺🇸 Colorado Springs, Colorado, United States

511.156.01042 Boehringer Ingelheim Investigational Site; 🇺🇸 Deland, Florida, United States

511.156.01047 Boehringer Ingelheim Investigational Site; 🇺🇸 Fort Lauderdale, Florida, United States

511.156.01059 Boehringer Ingelheim Investigational Site; 🇺🇸 Birmingham, Alabama, United States

511.156.01076 Boehringer Ingelheim Investigational Site; 🇺🇸 Little Rock, Arkansas, United States

511.156.01069 Boehringer Ingelheim Investigational Site; 🇺🇸 Tuscon, Arizona, United States

511.156.01022 Boehringer Ingelheim Investigational Site; 🇺🇸 Coral Gables, Florida, United States

511.156.01011 Boehringer Ingelheim Investigational Site; 🇺🇸 Gainseville, Florida, United States

511.156.01025 Boehringer Ingelheim Investigational Site; 🇺🇸 Chicago, Illinois, United States

511.156.01029 Boehringer Ingelheim Investigational Site; 🇺🇸 Greensboro, North Carolina, United States

511.156.01052 Boehringer Ingelheim Investigational Site; 🇺🇸 Fargo, North Dakota, United States

511.156.01037 Boehringer Ingelheim Investigational Site; 🇺🇸 Poughkeepsie, New York, United States

511.156.02017 Boehringer Ingelheim Investigational Site; 🇨🇦 Winnipeg, Manitoba, Canada

511.156.02003 Boehringer Ingelheim Investigational Site; 🇨🇦 Saskatoon, Saskatchewan, Canada

511.156.02014 Boehringer Ingelheim Investigational Site; 🇨🇦 Victoria, British Columbia, Canada

511.156.02010 Boehringer Ingelheim Investigational Site; 🇨🇦 Coquitlam, British Columbia, Canada

511.156.01048 Boehringer Ingelheim Investigational Site; 🇺🇸 Anderson, South Carolina, United States

511.156.01050 Boehringer Ingelheim Investigational Site; 🇺🇸 Fort Worth, Texas, United States

511.156.02002 Boehringer Ingelheim Investigational Site; 🇨🇦 Quebec, Canada

511.156.02009 Boehringer Ingelheim Investigational Site; 🇨🇦 Vancouver, British Columbia, Canada

511.156.02008 Boehringer Ingelheim Investigational Site; 🇨🇦 Mount Pearl, Newfoundland and Labrador, Canada

511.156.01041 Boehringer Ingelheim Investigational Site; 🇺🇸 Chattanooga, Tennessee, United States

511.156.02004 Boehringer Ingelheim Investigational Site; 🇨🇦 Calgary, Alberta, Canada

511.156.01003 Boehringer Ingelheim Investigational Site; 🇺🇸 Austin, Texas, United States

511.156.02001 Boehringer Ingelheim Investigational Site; 🇨🇦 Halifax, Nova Scotia, Canada

511.156.01060 Boehringer Ingelheim Investigational Site; 🇺🇸 Memphis, Tennessee, United States

511.156.02007 Boehringer Ingelheim Investigational Site; 🇨🇦 Woodstock, New Brunswick, Canada

511.156.02012 Boehringer Ingelheim Investigational Site; 🇨🇦 Winnipeg, Manitoba, Canada

511.156.01091 Boehringer Ingelheim Investigational Site; 🇺🇸 Jackson, Tennessee, United States

511.156.01051 Boehringer Ingelheim Investigational Site; 🇺🇸 Fort Lauderdale, Florida, United States

511.156.01070 Boehringer Ingelheim Investigational Site; 🇺🇸 Berkeley, California, United States

511.156.01016 Boehringer Ingelheim Investigational Site; 🇺🇸 Oceanside, California, United States

511.156.01084 Boehringer Ingelheim Investigational Site; 🇺🇸 Tucson, Arizona, United States

511.156.01053 Boehringer Ingelheim Investigational Site; 🇺🇸 Tuscon, Arizona, United States

511.156.01087 Boehringer Ingelheim Investigational Site; 🇺🇸 Los Angeles, California, United States

511.156.01075 Boehringer Ingelheim Investigational Site; 🇺🇸 La Mesa, California, United States

511.156.01038 Boehringer Ingelheim Investigational Site; 🇺🇸 San Diego, California, United States

511.156.01036 Boehringer Ingelheim Investigational Site; 🇺🇸 Denver, Colorado, United States

511.156.01092 Boehringer Ingelheim Investigational Site; 🇺🇸 Fort Collins, Colorado, United States

511.156.01027 Boehringer Ingelheim Investigational Site; 🇺🇸 New London, Connecticut, United States

511.156.01078 Boehringer Ingelheim Investigational Site; 🇺🇸 Lake Worth, Florida, United States

511.156.01095 Boehringer Ingelheim Investigational Site; 🇺🇸 Orlando, Florida, United States

511.156.01056 Boehringer Ingelheim Investigational Site; 🇺🇸 Columbus, Georgia, United States

511.156.01045 Boehringer Ingelheim Investigational Site; 🇺🇸 Marietta, Georgia, United States

511.156.01081 Boehringer Ingelheim Investigational Site; 🇺🇸 Savannah, Georgia, United States

511.156.01066 Boehringer Ingelheim Investigational Site; 🇺🇸 Boise, Idaho, United States

511.156.01089 Boehringer Ingelheim Investigational Site; 🇺🇸 South Bend, Indiana, United States

511.156.01034 Boehringer Ingelheim Investigational Site; 🇺🇸 New Orleans, Louisiana, United States

511.156.01008 Boehringer Ingelheim Investigational Site; 🇺🇸 Lexington, Kentucky, United States

511.156.01074 Boehringer Ingelheim Investigational Site; 🇺🇸 Boston, Massachusetts, United States

511.156.01012 Boehringer Ingelheim Investigational Site; 🇺🇸 Shreveport, Louisiana, United States

511.156.01080 Boehringer Ingelheim Investigational Site; 🇺🇸 Haverhill, Massachusetts, United States

511.156.01006 Boehringer Ingelheim Investigational Site; 🇺🇸 Detroit, Michigan, United States

511.156.01086 Boehringer Ingelheim Investigational Site; 🇺🇸 Paw Paw, Michigan, United States

511.156.01055 Boehringer Ingelheim Investigational Site; 🇺🇸 Plainsboro, New Jersey, United States

511.156.01001 Boehringer Ingelheim Investigational Site; 🇺🇸 New Brunswick, New Jersey, United States

511.156.01005 Boehringer Ingelheim Investigational Site; 🇺🇸 Chaska, Minnesota, United States

511.156.01013 Boehringer Ingelheim Investigational Site; 🇺🇸 Olive Branch, Mississippi, United States

511.156.01009 Boehringer Ingelheim Investigational Site; 🇺🇸 Bronx, New York, United States

511.156.01031 Boehringer Ingelheim Investigational Site; 🇺🇸 Purchase, New York, United States

511.156.01024 Boehringer Ingelheim Investigational Site; 🇺🇸 Cary, North Carolina, United States

511.156.01065 Boehringer Ingelheim Investigational Site; 🇺🇸 Charlotte, North Carolina, United States

511.156.01002 Boehringer Ingelheim Investigational Site; 🇺🇸 Raleigh, North Carolina, United States

511.156.01093 Boehringer Ingelheim Investigational Site; 🇺🇸 Bismarck, North Dakota, United States

511.156.01017 Boehringer Ingelheim Investigational Site; 🇺🇸 Beachwood, Ohio, United States

511.156.01033 Boehringer Ingelheim Investigational Site; 🇺🇸 Cincinnati, Ohio, United States

511.156.01032 Boehringer Ingelheim Investigational Site; 🇺🇸 Cincinnati, Ohio, United States

511.156.01068 Boehringer Ingelheim Investigational Site; 🇺🇸 Englewood, Ohio, United States

511.156.01077 Boehringer Ingelheim Investigational Site; 🇺🇸 Ashland, Oregon, United States

511.156.01082 Boehringer Ingelheim Investigational Site; 🇺🇸 Philadelphia, Pennsylvania, United States

511.156.01094 Boehringer Ingelheim Investigational Site; 🇺🇸 West Reading, Pennsylvania, United States

511.156.01083 Boehringer Ingelheim Investigational Site; 🇺🇸 Warwick, Rhode Island, United States

511.156.01058 Boehringer Ingelheim Investigational Site; 🇺🇸 Greenville, South Carolina, United States

511.156.01073 Boehringer Ingelheim Investigational Site; 🇺🇸 Bristol, Tennessee, United States

511.156.01085 Boehringer Ingelheim Investigational Site; 🇺🇸 Watertown, South Dakota, United States

511.156.01035 Boehringer Ingelheim Investigational Site; 🇺🇸 Germantown, Tennessee, United States

511.156.01054 Boehringer Ingelheim Investigational Site; 🇺🇸 Dallas, Texas, United States

511.156.01014 Boehringer Ingelheim Investigational Site; 🇺🇸 Houston, Texas, United States

511.156.01015 Boehringer Ingelheim Investigational Site; 🇺🇸 Richmond, Virginia, United States

511.156.01020 Boehringer Ingelheim Investigational Site; 🇺🇸 Seattle, Washington, United States

511.156.01090 Boehringer Ingelheim Investigational Site; 🇺🇸 Richmond, Virginia, United States

511.156.02006 Boehringer Ingelheim Investigational Site; 🇨🇦 Burlington, Ontario, Canada

511.156.02016 Boehringer Ingelheim Investigational Site; 🇨🇦 Toronto, Ontario, Canada

511.156.02015 Boehringer Ingelheim Investigational Site; 🇨🇦 Sherbrooke, Quebec, Canada

511.156.01028 Boehringer Ingelheim Investigational Site; 🇺🇸 Chicago, Illinois, United States

511.156.01021 Boehringer Ingelheim Investigational Site; 🇺🇸 Roswell, Georgia, United States

511.156.01026 Boehringer Ingelheim Investigational Site; 🇺🇸 Winston-Salem, North Carolina, United States

511.156.02005 Boehringer Ingelheim Investigational Site; 🇨🇦 Ottawa, Ontario, Canada

511.156.02013 Boehringer Ingelheim Investigational Site; 🇨🇦 Barrie, Ontario, Canada